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RESPONSE TO FEDERAL HEALTH MINISTER'S ANNOUNCEMENT ON GLP-1 AGONISTS COMPOUNDING LOOPHOLE CLOSURE

The following is an open letter from the ASCP made on the 22nd of May 2024 in response to the Federal Health Minister’s Announcement on “GLP-1 Agnoists Compounding Loophole Closure”:

Dear Members of the Media,

The Australian Society of Compounding Pharmacists (ASCP) emphasises the upholding of regulations, guidelines, and standards governing the practice of quality compounding. Compounding should be executed by suitably trained registered pharmacists in appropriately resourced pharmacy facilities for the purpose of fulfilling specific patient needs. The current compounding laws support uninterrupted patient access to essential medicines. Pharmacists who prepare sterile compounded medicines must follow either the PIC/S Guide to Good Manufacturing Practice or the revised USP General Chapter <797> for Sterile Compounding, as per the Guidelines on compounding of medicines (Pharmacy Board of Australia).

Non-compliance to the laws and standards, leading to the potential for patient harm - such as the recent reports related to some compounded semaglutide - is highly concerning. Strong ramifications should be imposed on the individual(s) who are found to be placing the public at risk. Practitioners providing a valuable service to patients must be able to continue to do so. Options other than an outright ban were proposed to the TGA regarding the compounding of GLP-1 RAs, so that non-compliant practitioners are prohibited. Alternative options include audits, inspections and certifications by appropriate bodies to which the regulators agree on a national level. In South Australia, PRASA already has a similar process where, prior to sterile compounding, pharmacists must undergo a Risk Assessment process.

ASCP urges the Minister to adopt a systematic approach that prohibits only those individuals who fail to adhere to these compounding standards. We encourage the Minister to collaborate with industry partners to develop a process that mitigates risk in a measured and non-reactionary manner. Completely restricting patient access to medication, especially life-saving treatments, is a significant public health concern.

ASCP remains dedicated to advocating for responsible and safe compounding practices that prioritise patient care and safety. We support continued dialogue with regulatory bodies to ensure that compounding remains an integral and accessible part of Australia's healthcare system.

Australian Society of Compounding Pharmacists (ASCP)

Email: info@ascp.net.au

Website: www.ascp.net.au

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The Australian Society of Compounding Pharmacists (ASCP) stands firm in its commitment to the upholding of regulations, guidelines, and standards governing the practice of quality compounding. Our organisation serves as a dedicated advocate for striking the delicate balance between regulatory measures and ensuring uninterrupted patient access to essential medicines.

We stress our support of the current regulatory framework, which offers comprehensive guidelines for both sterile and non-sterile compounding processes. Pharmacists are urged to conduct thorough risk assessments of all facets of compounding practice, ensuring strict adherence to the guidelines outlined by the Pharmacy Board of Australia in the Guidelines on compounding of medicines.

This includes meticulous consideration of compounding circumstances, coupled with the provision of evidence pertaining to the efficacy, safety, quality, and stability of compounded medications.

Pharmacists who prepare sterile compounded medicines are reminded that the revised USP General Chapter <797> for Sterile Compounding, which came into force on 1st November, 2023, is the appropriate guidance document which must be adhered to, unless they are following PIC/S Guide to Good Manufacturing Practice. We highlight the importance of adhering to guidelines and standards, when compounding high risk medications such as sterile medicines, including GLP-1 RAs during times of medication shortage, in order to serve patients’ identified needs.

Membership to ASCP is available at www.ascp.net.au.